Comparative Effects of Clamshell Technique With EMS vs CTin Iliotibial Band Tightness for Pain and Function

Comparative Effects of Clamshell Technique With Electrical Muscle Stimulation Versus Conservative Treatment in Iliotibial Band Tightness for Pain and Function

Iliotibial band syndrome (ITBS) is a common knee injury that usually presents with pain and/or tenderness on palpation of the lateral aspect of the knee, superior to the joint line and inferior to the lateral femoral epicondyle. The current theory is that this condition is likely to be caused by compression of the innervated tissues beneath the iliotibial band (ITB), leading to inflammation.

Study Overview

• Status: Active, not recruiting
• Conditions: Tibial Muscular Dystrophy
• Intervention / Treatment: Diagnostic test: Clamshell exercises with Electrical Muscle Stimulation (CT + EMS); Other: Conservative Treatment (CT)

Detailed Description

There were effects of clamshell exercises on gluteus medius, quadratus lumborum and anterior hip flexor. However their effect was limited on iliotibial band tightness. Hip/knee coordination and running style have also been identified as key factors in the treatment of ITBS, highlighting the complexity of the condition. The present study will focus on effect of clamshell techniques with electrical muscle stimulation versus Conservative treatment in iliotibial band tightness for pain and function.The goal is to determine which technique is more effecient in improving function and reducing pain and soreness of Iliotibial band.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan
      • The University of Lahore Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 45-65 years old (Jeong et al., 2019)
• Both genders will be included (Jeong et al., 2019)
• Diagnosed with iliotibial band tightness (ITBT) based on clinical examination and positive Noble compression test (Hutchinson et al., 2022)
• Reporting lateral knee pain aggravated by activity (Hutchinson et al., 2022)

Exclusion Criteria:

• Recent history of knee surgery or other knee injuries (Peterson et al., 2022)
• Presence of other musculoskeletal conditions affecting the knee (Peterson et al., 2022)
• Inflammatory conditions such as rheumatoid arthritis or gout (Peterson et al., 2022)
• Neurological conditions affecting leg function (Peterson et al., 2022)
• Pregnancy (Jeong et al., 2019)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clamshell exercises with Electrical Muscle Stimulation (CT + EMS)	Diagnostic test: Clamshell exercises with Electrical Muscle Stimulation (CT + EMS); Side-lying clamshells: 3 sets of 10 repetitions per leg, 3 times per week Hip abduction with theraband: 3 sets of 10 repetitions per leg, 3 times per week Bridge with hip abduction: 3 sets of 10 repetitions per leg, 3 times per week Electrical muscle stimulation: Applied to the gluteus medius and minimus muscles for 20 minutes per session, 3 times per week Frequency and intensity adjusted to individual tolerance
Other: Conservative Treatment (CT)	Other: Conservative Treatment (CT); Stretching: Iliotibial band stretch: 30-second hold, 3 repetitions per leg, 2 times per day Quadriceps stretch: 30-second hold, 3 repetitions per leg, 2 times per day Hamstring stretch: 30-second hold, 3 repetitions per leg, 2 times per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measured using a numeric pain rating scale (NPRS)	ranging from 0 (no pain) to 10 (worst imaginable pain) assessed at baseline, after intervention, and at 1-month follow-up.	12 Months
Lower Extremity Functional Scale (LEFS)	Measured using the Lower Extremity Functional Scale (LEFS) assessed at baseline, after intervention, and at 1-month follow-up	12 months
ITBT length	Measured using a goniometer at baseline, after intervention, and at 1-month follow-up.	12 months
Range of motion (ROM):	Measured using a goniometer for knee flexion and extension at baseline, after intervention, and at 1-month follow-up."	12 months

Collaborators and Investigators

• Sponsor: Superior University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Actual): April 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: May 20, 2024
• First Submitted That Met QC Criteria: May 20, 2024
• First Posted (Actual): May 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 24, 2024
• Last Update Submitted That Met QC Criteria: May 20, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Genetic Diseases, Inborn; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Muscular Disorders, Atrophic; Muscular Dystrophies; Distal Myopathies
• Other Study ID Numbers: MSRSW/Batch-Fall22/709

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No